Laboratory Compliance
Laboratory compliance is the ongoing effort of clinical labs to meet certain standards of practice set by various government agencies. Most prominent of these are the Clinical Laboratory Improvement Amendments (CLIA), which establish Quality Assurance (QA) standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed.
CLIA requires clinical laboratories to be certified by their state as well as the Center for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing. Laboratories can obtain multiple types of CLIA certificates, based on the kinds of diagnostic tests they conduct.
Certification is also required to receive reimbursements from Medicare or Medicaid.
CLIA 88 requires Quality Assurance assessment of all labs for these QA standards:
- Patient test management
- Quality control
- Proficiency testing
- Test comparisons
- Relate results to clinical data
- Personnel
- Communications
- Complaints
- Staff review
- Records
These QA standards for laboratory compliance encompass a range of activities that enable laboratories to achieve and maintain high levels of accuracy and proficiency despite changes in test methods and the volume of specimens tested. According to the CDC, good QA system achieves these four things:
- Establishes standard operating procedures (SOPs) for each step of the laboratory testing process, ranging from specimen handling to instrument performance validation
- Defines administrative requirements, such as mandatory recordkeeping, data evaluation, and internal audits to monitor adherence to SOPs
- Specifies corrective actions, documentation, and the persons responsible for carrying out corrective actions when problems are identified
- Sustains high-quality employee performance
Three federal agencies are responsible for CLIA and laboratory compliance: The Food and Drug Administration (FDA), Center for Medicaid Services (CMS) and the Center for Disease Control (CDC). Each agency has a unique role in assuring quality laboratory testing.
FDA
- Categorizes tests based on complexity
- Reviews requests for Waiver by Application
- Develops rules/guidance for CLIA complexity categorization
CMS
- Issues laboratory certificates
- Collects user fees
- Conducts inspections and enforces regulatory compliance
- Approves private accreditation organizations for performing inspections, and approves state exemptions
- Monitors laboratory performance on Proficiency Testing (PT) and approves PT programs
- Publishes CLIA rules and regulations
CDC
- Provides analysis, research, and technical assistance
- Develops technical standards and laboratory practice guidelines, including standards and guidelines for cytology
- Conducts laboratory quality improvement studies
- Monitors proficiency testing practices
- Develops and distributes professional information and educational resources
- Manages the Clinical Laboratory Improvement Advisory Committee (CLIAC)
Digital Pathology Systems Will Create Opportunities
CEO SUMMARY: Advanced Pathology Associates, a 15-member private pathology group practice, had the distinction of generating data for the clinical study that Philips submitted to the Food and Drug Administra…
Labs: Watch for Whistleblowers! You Can’t Predict Who’s Filing
NEWS STORIES ABOUT TWO DIFFERENT FEDERAL WHISTLEBLOWER CASES against lab companies provide a reminder that managers of every clinical laboratory and pathology group must be vigilant about compliance, because potential whistleblowers can emerge from the unlikeliest of places. The first example involv…
Mississippi Blue Cross Sues Hospital, Tox Labs
CEO SUMMARY: Last month’s lawsuit filed by Blue Cross Blue Shield of Mississippi against a small rural hospital in Mississippi and multiple defendant lab companies in Texas is the latest attempt by health insurers to rein the widespread fraud that threatens to overwhelm the pain managem…
31st Physician Pleads Guilty In Federal Lab Fraud Case
AN INTERNAL MEDICINE PHYSICIAN who practiced in Yonkers, N.Y., is the latest physician to admit to taking bribes in connection with a laboratory test referral scheme that Biodiagnostic Laboratory Services LLC (BLS), of Parsippany, N.J., operated for years. The physician, Ricky J. Sayegh, MD, 44, of …
Proposed Bill in Congress Would Regulate LDTs
CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both …
Federal Regulation of LDTs Subject of Proposed Bill
THERE’S A NEW BATTLE over laboratory-developed tests (LDTs) looming on Capitol Hill. In response to the FDA’s draft guidance to regulate LDTs, a bill has been proposed by two members of the house that would shape LDT regulations in different ways than proposed by the FDA. The Diagnostic Accuracy…
CMS Extends Reporting of Payer Prices by 60 Days
CEO SUMMARY: Last Thursday, the federal Centers for Medicare and Medicaid Services said it was extending the deadline for certain labs to report their private payer lab test prices by an additional 60 days, until May 30. Statements by CMS officials indicate that either or both the number …
Expense of Phlebotomy Leases Raise Cost of Care in Australia
CEO SUMMARY: In the United States, medical labs have long recognized that paying over-market rates to lease phlebotomy space in physicians’ officers is an inducement and a violation of federal anti-kickback laws. In Australia, a law in 2010 that removed the cap on what labs could pay to…
Patient Privacy Breach at Quest Attracts National News Coverage
IT WAS NATIONAL NEWS RECENTLY when Quest Diagnostics Incorporated disclosed a security breach involving the protected health information (PHI) of 34,000 individual customers. This episode is a reminder to clinical labs and pathology groups of the need to guard protected health infor…
PAMA Reporting Penalties Can Be Substantial for Laboratories
STARTING JAN. 1, 2017, there are substantial penalties for labs that fail to properly meet the complex lab test price marketing reporting requirements of the Protecting Access to Medicare Act of 2014. Labs that fail to do so face the potential of stiff, multi-million dollar fines. “Under PAMA, cli…
CURRENT ISSUE
Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
See the full table of contentsHow Much Laboratory Business Intelligence Have You Missed?
Lab leaders rely on THE DARK REPORT for actionable intelligence on important developments in the business of laboratory testing. Maximize the money you make-and the money you keep! Best of all, it is released every three weeks!
Sign up for TDR Insider
Join the Dark Intelligence Group FREE and get TDR Insider FREE!
Never miss a single update on the issues that matter to you and your business.